Oklahoma Judge Excludes Lab Results on Explanted Knee Implant

A federal judge in Oklahoma has granted motions by Zimmer Inc. to exclude evidence and testimony from a laboratory’s analysis of an artificial knee implant that failed two years after being implanted.

Judge Claire V. Egan of the U.S. District Court for the Northern District of Oklahoma ruled on March 6th that a combination of “misapplications” that occurred during inspection of plaintiff Brian Howard’s explanted device render the lab’s report unreliable under federal evidentiary standards.

Howard filed his complaint in 2002, alleging that the Sulzer Natural Knee II (NK-II) baseplate he had surgically implanted two years before was defectively designed. Specifically, the lawsuit asserted that the surface of the artificial knee contained hydrocarbon residue that should have been removed during manufacturing. Howard claimed that as a result of the defect, the baseplate failed to adequately bond with bone in his knee, triggering a painful inflammatory response and additional injuries that resulted in a second surgery to replace the implant.

There were numerous complaints being filed at the same time Howard filed his suit, involving allegedly defective Sulzer-NK-II knee implants, which were transferred to a coordinated multidistrict litigation (MDL) docket in the U.S. District Court for the Northern District of Ohio. The cases eventually settled, but Howard’s lawsuit was not among those eligible for settlement proceeds because his NK-II was not among those identified in the agreement as an “affected lot.”

Howard’s case was remanded to the U.S. District Court for the Northern District of Oklahoma where defendant Zimmer moved to exclude a lab report and also sought to exclude opinions of three doctors testifying on Howard’s behalf as unreliable.

Chemir was the company hired to examine Howard’s explanted device. Zimmer maintained that the methodology used by Chemir was flawed and should be deemed excluded.

Zimmer identified four problems with Chemir’s methodology, including failure to maintain custody of the device, arguing that as a result, it is possible that hydrocarbons detected on the surface of the device could have come from contamination and post-explant handling.

In addition, Chemir’s failure to conduct a sample extraction of the implant’s container, which Zimmer argued could have been made of plastic, represented a potential source of hydrocarbons detected in the lab’s analysis, the motion to exclude stated.

Defendant also stated that Chemir’s failure to conduct a sample extraction of all three parts of Howard’s implant, instead of performing control extractions of each part separately, and that the lab failed to test the same oils used in the manufacturing process of the implant are more reason to exclude the lab report. Instead, the lab analyzed a commercially available mineral oil not used in the implant’s manufacturing process, Zimmer said.

Judge Eagan noted that the combination of all four errors cited by Zimmer is sufficient and the motion should be granted to the extent it seeks exclusion of the Chemir report. In addition, the Judge said that there was no evidence that further scientific inquiry was conducted regarding the extent of similarities between Brian Howard’s experiences and those of the other patient.

We will continue to keep you up to date as proceedings in this lawsuit develop, although the Judge’s ruling here comes as bad news to the plaintiff.

For more information regarding Sulzer-NK-II lawsuits, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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